N/A
N=153
Product Evaluation of a Newly Developed Intermittent Catheter.
Incontinence, Urinary
Bottom Line
View on ClinicalTrials.gov: NCT02966015 ↗Enrolled (actual)
153
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Number of Participants Successfully Able to Insert Catheter — 82; 58 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Coloplast test catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Coloplast A/S
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Successfully Able to Insert Catheter |
82; 58 | — |
Summary
The aim of the study is to investigate the navigation of a newly developed catheter.
Eligibility Criteria
Inclusion Criteria
- Male and at least 18 years
- Has used Intermittent self-catheterization at least 3 months
- Has normal to slightly reduced hand mobility
- Use catheter size CH12 or CH14 (must use same size during product evaluation)
Exclusion Criteria
- Currently receiving treatment for urinary tract infection
- Currently receiving chemotherapy
Data sourced from ClinicalTrials.gov (NCT02966015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.